The present invention relates to a urinary incontinence device and a method of using the device. More specifically, this invention relates to a urinary incontinence device which is designed to be placed inside a vagina for providing support to the urethra to prevent the involuntary urine loss commonly associated with stress urinary incontinence.
Some women, especially women who have given birth to one or more children, and older women, can experience incidences of involuntary urine loss due to stress urinary incontinence or combined stress and urge incontinence. A sneeze or cough can increase the intra-abdominal pressure impinging on a person""s bladder and cause the involuntary release of urine. The frequency and severity of such urine loss can increase as the muscles and tissues near the urethro-vaginal myofascial area grow weaker. It has also been recognized that the urinary sphincter muscle, which is located at the upper end of the urethra adjacent to the bladder, works well at sealing off the passing of urine from the bladder to the urethra when it has a round or circular cross-sectional configuration. However, when this passageway becomes distorted into a cross-sectional configuration having more of an elliptical or oval appearance, the sphincter muscle cannot close properly, therefore, the tendency for involuntary urine loss increases. As the world""s female population ages, there is an ever increasing need for a nonsurgical procedure to reduce the involuntary urine loss commonly associated with stress urinary incontinence. Today, there are a number of products available for this purpose. Essentially all of these products can only be purchased with a prescription and they need to be physically inserted and/or adjusted by a medical doctor or a nurse practitioner in order to perform correctly.
In view of the general lack of commercially available non-prescription urinary incontinence devices, it is recognized that there is a need for an effective urinary incontinence device which can be purchased without a prescription. There is also a need for a urinary incontinence device which is more user friendly and can be managed by the consumer without the intervention of a medical practitioner. Furthermore, there is a need for a urinary incontinence device which is easy for women to insert into and remove from their bodies, is more comfortable to wear, and which provides psychological and realistic assurance that it is capable of properly performing over an extended period of time.
In one aspect of the invention, a device is provided for reducing the occurrence and/or severity of female incontinence. The device includes an incontinence insert, a withdrawal member, and a single piece applicator. The incontinence insert is adapted to be placed in a vagina to at least partially reduce incontinence. The insert has a first end portion and a second end portion. The withdrawal member is attached to at least one of the first end portion and the second end portion of the incontinence insert, and the withdrawal member includes a stopping member. The single piece applicator has a leading end portion and a trailing end portion, and the leading end portion engages the incontinence insert. The trailing end portion is adapted to releasably secure the stopping member against movement in at least one direction.
In another aspect of the invention, a device includes a single piece applicator having a trailing end portion and a leading end portion, and an expandable insert having an expanded position and a contracted position. The insert is adapted to be placed in a vagina to at least partially reduce incontinence. The leading end portion of the applicator engages the insert while the insert is in its contracted position.
In yet another aspect of the invention, a method of placing an incontinence insert within a vagina is provided. The method includes inserting an incontinence device into a vagina, the device including a single piece applicator and an expandable incontinence insert. The insert is released from the single piece applicator. The single piece applicator is then withdrawn from the vagina.
Other aspects of the invention will be apparent to those skilled in the art in view of the claims following the detailed description of the presently preferred embodiments.